Who is the manufacturer of CORE 500 Digital Stethoscope?

Eko Devices, Inc. filed the 510(k) submission for CORE 500 Digital Stethoscope (K230111).

What is the FDA product code for CORE 500 Digital Stethoscope?

DQD. It is classified under 21 CFR 870.1875 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for CORE 500 Digital Stethoscope?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like CORE 500 Digital Stethoscope?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CORE 500 Digital Stethoscope

Q: What are the predicate devices for CORE 500 Digital Stethoscope?

Eko Model E5 System (EME5), Eko DUO (K170874).

K230111 · Eko Devices, Inc. · DQD · May 26, 2023 · Cardiovascular

Device Facts

Record ID	K230111
Device Name	CORE 500 Digital Stethoscope
Applicant	Eko Devices, Inc.
Product Code	DQD · Cardiovascular
Decision Date	May 26, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1875
Device Class	Class 2
Attributes	Pediatric

Intended Use

The CORE 500 Digital Stethoscope is intended to be used by clinicians to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500 Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician). The data offered by the device is only significant when used in conjunction with clinician evaluation as well as consideration of other relevant patient data.

Device Story

Electronic stethoscope with integrated electrodes; captures body sounds (phonocardiogram) and 3-lead ECG; transmits data via Bluetooth to mobile application. Features Cardiac, Pulmonary, and Wide Band auscultation modes; provides real-time heart rate computation based on PCG data. Used by clinicians in clinical settings for physical assessment. Device includes chestpiece, earpiece, and mobile app. Output displayed on device screen and app; assists clinicians in evaluating cardiac, pulmonary, and abdominal sounds; supports clinical decision-making by providing amplified audio and ECG waveforms for diagnostic context.

Clinical Evidence

Bench testing only. Performance validated through audio performance testing, electrical/mechanical function verification, and heart rate measurement accuracy. Biocompatibility confirmed per ISO 10993-1. Electrical safety and EMC compliance verified per IEC 60601 standards.

Technological Characteristics

Electronic stethoscope with 3 dry electrodes for ECG. Connectivity: Bluetooth Low Energy (BLE). Power: 3.7V rechargeable Lithium-ion battery. Audio frequency range: 20 Hz - 2000 Hz. ECG frequency range: 0.1 - 250 Hz. Hardware interface: display, mode button, volume button, capacitive touch. Software: mobile application integration. Biocompatibility: ISO 10993-1 compliant. Safety/EMC: IEC 60601-1, IEC 60601-2-47, IEC 60601-1-2.

Indications for Use

Indicated for use by clinicians on adult and pediatric patients to amplify, filter, and transfer body sounds and 3-lead ECG waveforms for physical assessment.

Regulatory Classification

Identification

Manual stethoscope: A mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs. Electronic stethoscope: An electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

Special Controls

*Classification.* Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

Eko Model E5 System (EME5), Eko DUO (K170874)

Reference Devices

Eko Analysis Software (EAS) (K192004)

Related Devices

K201299 — HD Steth · Hd Medical, Inc. · Jul 10, 2020
K233609 — CORE 500 Digital Stethoscope · Eko Health, Inc. · Mar 28, 2024
K123148 — PARACE MD EKOSCOPE IS100 · Parace, LLC · Nov 19, 2013
K212709 — VoqX Electronic Stethoscope · Sanolla , Ltd. · Mar 15, 2022
K172296 — Stethee Pro · M3Dicine Pty , Ltd. · Oct 30, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it. May 26, 2023 Eko Devices, Inc. Sam Huang, Ph.D. Director of Regulatory Affairs 1212 Broadway, Suite 100 Oakland, California 94612 Re: K230111 Trade/Device Name: CORE 500 Digital Stethoscope Regulation Number: 21 CFR 870.1875 Regulation Name: Electronic Stethoscope Regulatory Class: Class II Product Code: DQD Dated: January 13, 2023 Received: January 17, 2023 Dear Sam Huang, Ph.D .: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Robert T. Kazmierski -S for LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K230111 Device Name CORE 500 Digital Stethoscope Indications for Use (Describe) The CORE 500 Digital Stethoscope is intended to be used by clinicians to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500 Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician). The data offered by the device is only significant when used in conjunction with clinician evaluation as well as consideration of other relevant patient data. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # GENERAL INFORMATION Applicant: Eko Devices, Inc. 1212 Broadway, Suite 100 Oakland, CA 94612 Phone: 844-356-3384 Contact Person: Sam Huang, Ph.D. Director of Regulatory Affairs Eko Devices, Inc. 1212 Broadway, Suite 100 Oakland, CA 94612 Date Prepared: January 13, 2023 # DEVICE INFORMATION Trade/Proprietary Name: CORE 500 Digital Stethoscope Regulation number: 21 CFR 870.1875 Device Classification Name: Electronic Stethoscope Regulatory Class: Class II Product Code: DQD, DPS ## PREDICATE DEVICE Predicate Device: Eko Model E5 System (EME5), Eko DUO (K170874) Reference Device: Eko Analysis Software (EAS) (K192004) ## DEVICE DESCRIPTION CORE 500 Digital Stethoscope (CORE 500) is an electronic stethoscope with integrated electrodes for electrocardiogram (ECG). The device consists of a chestpiece, detachable earpiece (Eko Earpiece) and a mobile application (Eko App) and is intended as a digital auscultation tool on patients requiring physical assessment by the health care providers. CORE 500 provides the ability to amplify, filter, and transfer body sounds with the chestpiece diaphragm, and three lead ECG through electrodes integrated around the chestpiece. CORE 500 features three auscultation modes for better auscultation experience by filtering acoustic data and enhancing the primary frequency range of particular body sounds: Cardiac Mode for heart sounds. Pulmonary Mode for lung sounds, and Wide Band Mode for general auscultation. CORE 500 also detects and computes the heart rate in real-time based on the phonocardiogram (PCG) data. {4}------------------------------------------------ # INDICATIONS FOR USE The CORE 500 Digital Stethoscope is intended to be used by clinicians to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500 Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician). The data offered by the device is only significant when used in conjunction with clinician evaluation as well as consideration of other relevant patient data. # SUBSTANTIAL EQUIVALENCE The CORE 500 Digital Stethoscope (CORE 500) is substantially equivalent to its predicate devices with regard to the intended use and the indications for use. Any differences in technological characteristics do not raise new questions on safety or effectiveness compared to the predicate device. A substantial equivalence comparison table between the subject device and the predicate device is provided below. {5}------------------------------------------------ Table 1 Substantial Equivalence Summary Comparison | | Subject Device: CORE 500 Digital Stethoscope | Predicate Device: Eko Model E5 System (EME5), Eko DUO (K170874) | Reference Device: Eko Analysis Software (EAS) (K192004) | Comparison | |---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Classification Name | Electronic Stethoscope | Electronic Stethoscope | Cardiac Monitor | Same as the predicate | | Regulation Number | 21 CFR 870.1875 | 21 CFR 870.1875 | 21 CFR 870.2300 | Same as the predicate | | Classification Product Code | DQD, DPS | DQD, DPS | MWI, DQD, DPS | Same as the predicate | | Indications for Use | The CORE 500 Digital Stethoscope is intended to be used by clinicians to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500 Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician). The data offered by the | The Eko Model E5 System is intended to be used by healthcare professionals to electronically amplify, filter, and transfer body sounds and single-channel electrocardiogram (ECG) waveforms. The Eko Model E5 System also displays ECG waveforms and phonocardiogram waveforms on the accompanying mobile application for storage and sharing (when prescribed or used under the care of a physician). It can be used to record heart sounds and cardiac | The Eko Analysis Software is intended to provide support to the physician in the evaluation of patients' heart sounds and ECG's. The software analyzes simultaneous ECG and heart sounds. The software will detect the presence of suspected murmurs in the heart sounds. The software also detects the presence of atrial fibrillation and normal sinus rhythm from the ECG signal. In addition, it calculates | Same intended use and indications for use as the predicate | | | Subject Device: CORE 500 Digital Stethoscope | Predicate Device: Eko Model E5 System (EME5), Eko DUO (K170874) | Reference Device: Eko Analysis Software (EAS) (K192004) | Comparison | | | device is only significant when used in conjunction with clinician evaluation as well as consideration of other relevant patient data. | murmurs, bruits, respiratory sounds, and abdominal sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary, or abdominal organ systems. The device can be used on adults and pediatrics. The data offered by the device is only significant when used in conjunction with physician over read as well as consideration of other relevant patient data. The device should not be used on infants weighing less than 10kg. | certain cardiac time intervals such as heart rate, QRS duration and EMAT. The software does not distinguish between different kinds of murmurs and does not identify other arrhythmias. It is not intended as a sole means of diagnosis. The interpretations of heart sounds and ECG offered by the software are only significant when used in conjunction with physician over-read and is for use on adults (> 18 years). | | | Patient Population | Adults and pediatric patients | Adults and pediatric patients | Adults (> 18 years) | Same as the predicate | | Prescribed | Prescription Only | Prescription Only | Prescription Only | Same as the predicate | | Technological Characteristics Comparison | | | | | | | Subject Device: CORE 500 Digital Stethoscope | Predicate Device: Eko Model E5 System (EME5), Eko DUO (K170874) | Reference Device: Eko Analysis Software (EAS) (K192004) | Comparison | | Type of Data Acquired | Body sounds and ECG | Body sounds and ECG | N/A as EAS is a standalone software | Same as the predicate | | Connectivity | Bluetooth Low Energy (BLE) | Bluetooth Low Energy (BLE) | N/A as EAS is a standalone software | Same as the predicate | | Battery Type | Rechargeable Lithium-ion, 3.7V | Rechargeable lithium-ion, 3.7V | N/A as EAS is a standalone software | Same as the predicate | | Audio Frequency Range | 20 Hz - 2000 Hz | 20 Hz - 2000 Hz | N/A as EAS is a standalone software | Same as the predicate | | ECG Frequency Range | 0.1 - 250 Hz | 0.15 - 200 Hz | N/A as EAS is a standalone software | Similar to the predicate. The subject device has wider frequency range that does not raise different questions of safety and effectiveness | | Mechanism of Action | User places the device on the body for auscultation. The device simultaneously captures ECG, and Audio data which is transmitted via | User places the device on the body for auscultation. The device simultaneously captures ECG, and Audio data which is transmitted via Bluetooth to the | N/A as EAS is a standalone software | Same as the predicate | | | Subject Device: CORE 500 Digital Stethoscope | Predicate Device: Eko Model E5 System (EME5), Eko DUO (K170874) | Reference Device: Eko Analysis Software (EAS) (K192004) | Comparison | | | Bluetooth to the Mobile application. | Mobile application. | | | | No. of ECG Electrodes | Three (3) dry electrodes | Two (2) dry electrodes | N/A as EAS is a standalone software | Different. The technology characteristic difference does not raise different questions of safety and effectiveness | | Hardware Interface | Display Mode Button Volume Button Capacitive touch | Mode Button Volume Button | N/A as EAS is a standalone software | Similar to the predicate. The additional interfaces do not raise different questions of safety and effectiveness | | Software Interface | Mobile Application (Eko App) | Mobile Application (Eko App) | N/A as EAS is a standalone software | Same as the predicate | | Recording and Playback | Yes | Yes | N/A as EAS is a standalone software | Same as the predicate | | Heart Rate Detection | PCG-based | N/A | ECG-based and/or PCG- based | Similar to the reference | | | Subject Device: CORE 500 Digital Stethoscope | Predicate Device: Eko Model E5 System (EME5), Eko DUO (K170874) | Reference Device: Eko Analysis Software (EAS) (K192004) | Comparison | | | | | | device | | Visualization of Sound and ECG Waveforms | Yes | Yes | N/A as EAS is a standalone software | Same as the predicate | | Auscultation Mode | Cardiac Mode Pulmonary Mode Wide Band Mode | Diaphragm Mode Pulmonary Mode Bell Mode | N/A as EAS is a standalone software | Similar to the predicate. The filter setting difference does not raise different questions of safety and effectiveness | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ # PERFORMANCE DATA - NONCLINICAL TESTING SUMMARY The following performance data were provided in support of the substantial equivalence determination. # Biocompatibility Biological evaluations were conducted with the CORE 500 Digital Stethoscope according to ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. The evaluation report concluded that the CORE 500 Digital Stethoscope is biocompatible. # Electrical safety and electromagnetic compatibility (EMC) Electrical safety and EMC testing were conducted and demonstrated CORE 500 Digital Stethoscope complies with IEC 60601-1. IEC 60601-2-47 standard for safety, IEC 60601-1-2 for electromagnetic compatibility. ## Software verification and validation testing The software of this device is verified and validated according to Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. ## Bench testing The CORE 500 Digital Stethoscope has gone through rigorous bench testing to demonstrate the product performance, and confirmed that differences between the subject and predicate device do not raise different questions of safety and effectiveness. The testing includes the following: - · Audio performance - Electrical and mechanical function verification, and - Heart rate measurement ## CONCLUSIONS The indications for use, technological characteristics and performance testing support that the proposed device, the CORE 500 Digital Stethoscope is substantially equivalent, and as safe and effective as the predicate device, and raises no new issues of safety or effectiveness.